Antiviral Effect, Safety, and Pharmacokinetics of BI201335 +PegIFN/RBV in HCV-GT1 (SILEN-C1&2)

Inclusion criteria:

chronic HCV GT1; therapy-naive to IFN, PegIFN, or RBV; HCV VL >=100,000 IU/mL Liver biopsy
within 2 years prior to study enrolment showing necroinflammatory activity or presence of
fibrosis Normal retinal finding on fundoscopy within 6 months prior to Day 1 age 18-65
years Females and males with adequate contraception

Exclusion criteria:

Mixed genotype (1/2, 1/3, or 1/4), diagnosed by genotypic testing at screening Previous
treatment with protease inhibitor Evidence of liver disease due to causes other than
chronic HCV infection HIV-1 or HIV-2 positive HBV positive Decompensated liver disease, or
history of decompensated liver disease Active or suspected malignancy or history of
malignancy within the last 5 years History of alcohol or drug abuse within the past 12
months. Usage of any investigational drug within 30 days prior to enrolment, or 5
half-lives, whichever is longer Known hypersensitivity to any ingredient of the study
drugs Condition that is defined as one which in the opinion of the investigator may put
the patient at risk because of participation in the study or may influence the results of
the study or the patient's ability to participate in the study Alpha-fetoprotein value >
100ng/mL at screening; if >20ng/mL and <=100ng/mL, patients can be included if there is no
evidence of liver cancer in two congruent imaging studies Total bilirubin > 1.5x ULN wiht
ratio of direct/indirect >1. ALT or AST levels > 5x ULN INR prolonged to >1.5x ULN
Exclusion criteria related to PegIFN and/or RBV restrictions.